Adept Medical Ltd: Device Recall

Recall #Z-0963-2025 · 11/24/2024

Class II: Risk

Recall Details

Recall Number
Z-0963-2025
Classification
Class II
Product Type
Device
Recalling Firm
Adept Medical Ltd
Status
Ongoing
Date Initiated
11/24/2024
Location
Auckland, New Zealand
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,070 units (9090 US, 3980 OUS)

Reason for Recall

Lack of 510(k) clearance.

Product Description

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Distribution Pattern

US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.

Other Recalls by Adept Medical Ltd

View all recalls by Adept Medical Ltd →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.